FDA 483 - Yuki Gosei Kogyo Co., Ltd. - July 26, 2021

An FDA inspection of Yuki Gosei Kogyo Co., Ltd. in Iwaki, Fukushima, Japan, a drug substance manufacturer, revealed significant deficiencies in its quality unit and laboratory control systems. Observations included a failure to implement timely corrective actions for recurring data integrity issues with Distributed Control Systems, inadequate evaluation of alarm events, and a lack of effective CAPA for repeated HPLC system suitability failures. Additionally, the firm failed to perform working sample stability studies and lacked scientific justification for discarding original samples.